Gene patent holders have the right to prevent anyone from studying, testing or even examining a gene. As a result, scientific research and genetic testing is delayed, limited, or even shut down due to concerns about gene patents, and patients’ options about their medical care are restricted.
On May 14, The New York Times published a moving essay by Angelina Jolie where the actor revealed she had undergone a double mastectomy — even though she did not have breast cancer. However, Jolie was aware that she had inherited a genetic mutation that increased her risk of developing breast cancer to about 87 percent. That mutation, associated with a “BRCA gene,” additionally upped her chances for developing ovarian cancer to about 50 percent. Facing such grim odds, Jolie decided to be proactive and lower those risks by having her breasts and ovaries surgically removed.
The BRCA genes – BRCA1 and BRCA2 – are two genes that are associated with hereditary forms of breast and ovarian cancer. Everyone has these genes. BRCA1 and BRCA2 are tumor suppressor genes, which means that when they are functioning normally, they suppress the growth of cancerous cells. Women who have certain mutations along these genes have a higher lifetime risk of developing breast and ovarian cancer because their ability to suppress cancerous growth has been reduced. A woman with a BRCA mutation faces a 36 to 85 percent chance of contracting breast cancer and a 16 to 60 percent chance of ovarian cancer.
The U.S. Supreme Court is mulling a case that addresses legal and financial obstacles in the way of obtaining BRCA genetic testing, whether in the clinic or research lab. Those obstacles stem from a for-profit company’s claim to own patents on the BRCA genetic mutations themselves. That company, Myriad Genetics, contends that its discovery and isolation of those genes justifies its patent rights and, its authority to monopolize and regulate testing for BRCA gene mutations.
The case raises complex theoretical and legal questions about whether an isolated human gene should even be considered a patentable invention. Plaintiffs challenging Myriad’s patent argue that genes are considered more like gold: a miner who might discover a unique way to find and extract gold from earth is, nonetheless, not entitled to a patent on gold.
Plaintiffs contend that Myriad’s patents have allowed the company to charge exorbitant and unwarranted fees for BRCA testing: up to $3,000. This has not only created a financial obstacle for many women and men seeking testing, but it has also contributed to escalating health care costs. And because no other lab is free to do the test, patients have nowhere else to turn for confirmatory testing when false negative results from Myriad labs are suspected.
Moreover, since only Myriad can do the tests, it can, and does, keep any data it gleans from tests results, such as geographic and demographic patterns, or new genetic variants it may find. It has stopped sharing this data publicly, keeping it as its own trade secret so nobody else can use it to conduct research or develop therapies or tests.
Gene patenting doesn’t just stop with the breast and ovarian cancer genes. Over 20 percent of our genes are patented.
Myriad owns the patents to the genetic sequences, as well as any mutations along those genes. The American Civil Liberties Union, which has brought the case for a coalition of patients to the Supreme Court, researchers and doctors argues that this means that if genes from a particular person are analyzed or separated from other biological material, regardless of how or for what reason, that would constitute patent infringement.
For example, the case of muscular dystrophy, a genetic disorder that weakens the body’s muscles. A number of patents related to mutations in the dystrophin gene have been issued. If a parent were to have a young child’s genome sequenced, the doctor may not able to communicate any important results on the dystrophin gene because the right to do that belongs to the companies or people who control the intellectual property. The doctor, or the genome sequencing company, could be sued.
“The care available to patients should not be restricted because the naturally occurring building blocks of human biology have been inappropriately patented,” Dr. Jeremy A. Lazarus, president of the American Medical Association, said in a statement to NBC News. “Opportunities for scientific research and medical care based on human genes must stay available to all and exclusive to none.”
Researchers worry that gene patents limit research into whole genome sequencing, which then restricts the development of new treatments or tests for a broader number of diseases or conditions. The ability to do whole genome sequencing, to take a wide group of the human genome and to look for variants of clinical importance, limited by gene patents. If the patents are dropped, it would accelerate development of whole genome strategies for clinical purposes.
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